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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01569178
Other study ID # BAMI-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2013
Est. completion date November 27, 2019

Study information

Verified date April 2021
Source Queen Mary University of London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction(</=45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.


Recruitment information / eligibility

Status Completed
Enrollment 375
Est. completion date November 27, 2019
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - signed and dated informed consent form - men and women of any ethnic origin aged=18years - patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI (including new LBBB) - Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI. - Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow =2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis - Left ventricular ejection fraction = 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 2 to 6 days after reperfusion therapy - Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion Exclusion Criteria: - Participation in another clinical trial within 30 days prior randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting - Previously received stem/progenitor cell therapy - Pregnant or nursing women - Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol - Necessity to revascularise additional vessels, outside the target coronary artery at the time of progenitor cell infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time. - Cardiogenic shock requiring mechanical support - Platelet count <100.000/µl, or hemoglobin <8.5 g/dl - Impaired renal function, i.e. creatinine >2.5 mg/dl - Fever or diarrhoea not responsive to treatment within 4 weeks prior screening - Cliinically significant bleeding disorder within 3 months prior screening - Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) - Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bone Marrow aspiration and intracoronary reinfusion
Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique

Locations

Country Name City State
Belgium Cardiovascular Research Centre VZW Aalst
Belgium Katholieke Universiteit Leuven Leuven
Czechia Fakultni Nemocnice BRNO Brno
Denmark Region Hovedstaden Copenhagen
Finland Kuopio University Hospital Kuopio
Germany Zentralklinik Bad Berka Bad Berka
Germany Universitätsmedizin Charité Berlin Berlin
Germany UniLinikum Bonn Bonn
Germany Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie Dusseldorf
Germany HELIOS Klinikum Erfurt GmbH Erfurt
Germany University Hospital Essen Essen
Germany Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN Frankfurt
Germany Klinikum Fulda gAG Fulda
Germany Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med Greifswald
Germany UKSh Campus Lubeck, Med. Klinik II Lubeck
Germany Krankenhaus Hetzelstift Neustadt Neustadt
Germany SRH Zentralklinikum Suhl GmbH Suhl
Germany University Hospital Ulm, Clinic of Internal Medicine II Ulm
Italy Universita Cattolica Del Sacro Cuore Rome
Netherlands UMC Utrecht Utrecht
Spain Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario Clinico San Carlos Madrid
Spain Hospital Universitario Fundacion Alcorcon Madrid
Spain Hospital Universitario La Princesa Madrid
Spain Servico Madrileno De Salud Madrid
Spain Hospital Clinico Salamanca Salamanca
Spain H.U. Marques de Valdecilla Santander
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Clinico Universitario De Valladolid Valladolid
Spain Hospiatl Universitatio Miguel Servet Zaragoza
Switzerland Cardiocentro Ticino Lugano
United Kingdom Queen Mary, University of London (QMUL) London
United Kingdom New Cross Hospital, Royal Wolverhampton NHS Trust Wolverhampton

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary University of London

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Finland,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time from randomization to all-cause death for an average of 3 years
Secondary Time from randomization to cardiac death for an average of 3 years
Secondary time from randomization to cardiovascular rehospitalisation time from randomization to cardiovascular rehospitalisation for recurrent MI, coronary revascularisation procedures, heart failure, Implantation of ICD.CRT device, stroke, syncope or Arrhythmias for an average of 3 years
Secondary incidence and severity of adverse events for an average of 3 years
Secondary bleeding by BARC definition for an average of 3 years
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